Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
NCT ID: NCT04260854
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1
100 participants
INTERVENTIONAL
2024-01-24
2025-06-30
Brief Summary
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This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bupivacaine HCl
Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.
Bupivacaine Hydrochloride
Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
Saline
Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.
Saline
Normal saline injections.
Interventions
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Bupivacaine Hydrochloride
Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
Saline
Normal saline injections.
Eligibility Criteria
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Inclusion Criteria
2. Receiving cutaneous surgery
3. In good general health as assessed by the investigator
Exclusion Criteria
2. Participants unwilling to sign an IRB approved consent form
3. Participants with a contraindication to narcotic medication
4. Participants who are pregnant or will become pregnant
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
19 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor of Dermatology
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00211424
Identifier Type: -
Identifier Source: org_study_id
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